search
Back to results

Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Parecoxib sodium
Normal saline injection
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring preemptive analgesia, parecoxib sodium, total knee arthroplasty, total hip arthroplasty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
  2. Age between 18-65 years.
  3. Chinese ethnicity.

Exclusion Criteria:

  1. patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
  2. patient exhibited allergy to parecoxib sodium.
  3. lactating or pregnant.
  4. any other conditions not suitable for surgery as evaluated by the surgeon in charge.

Sites / Locations

  • The Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parecoxib sodium

Normal saline injection

Arm Description

The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.

The control group received 2 mL normal saline injection at the same time point.

Outcomes

Primary Outcome Measures

To evaluate the Morphine consumption in each group patients

Secondary Outcome Measures

To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration
To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty
Function recovery of knee Range of Motion (ROM) for patients received surgery

Full Information

First Posted
October 17, 2014
Last Updated
August 27, 2015
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02272660
Brief Title
Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty
Official Title
Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.
Detailed Description
Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management. We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
preemptive analgesia, parecoxib sodium, total knee arthroplasty, total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parecoxib sodium
Arm Type
Experimental
Arm Description
The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.
Arm Title
Normal saline injection
Arm Type
Placebo Comparator
Arm Description
The control group received 2 mL normal saline injection at the same time point.
Intervention Type
Drug
Intervention Name(s)
Parecoxib sodium
Other Intervention Name(s)
Dynastat
Intervention Description
The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Intervention Type
Drug
Intervention Name(s)
Normal saline injection
Other Intervention Name(s)
Physiological saline
Intervention Description
The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Primary Outcome Measure Information:
Title
To evaluate the Morphine consumption in each group patients
Time Frame
4 hours to 6 days after the surgery
Secondary Outcome Measure Information:
Title
To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration
Time Frame
4 hours to 6 days after the surgery
Title
To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty
Time Frame
4 hours to 6 days after the surgery
Title
Function recovery of knee Range of Motion (ROM) for patients received surgery
Time Frame
3 and 6 days after the surgery
Other Pre-specified Outcome Measures:
Title
Testing of body temperature,routine blood examination, IL-6 and IL-10
Time Frame
hospital admission and 1, 3, 6 days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA). Age between 18-65 years. Chinese ethnicity. Exclusion Criteria: patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma. patient exhibited allergy to parecoxib sodium. lactating or pregnant. any other conditions not suitable for surgery as evaluated by the surgeon in charge.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Wu, Prof
Organizational Affiliation
PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China

12. IPD Sharing Statement

Learn more about this trial

Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty

We'll reach out to this number within 24 hrs